보험인정기준 상세내용

■ 고시 신설 전체내용

허가사항 범위(성인 남성에서 탐스로신 단독요법에 적절히 반응하지 않는 양성 전립샘비대증에 따른 중등도 내지 중증 저장증상(빈뇨, 요절박) 및 배뇨증상의 치료) 내에서 투여 시 요양급여를 인정함.



■ 고시 신설 고시번호(시행일자)

고시 제2026-69호(2026.4.1.)



■ 고시 신설 사유

‘베솜니서방정’ 1품목이 신규 등재 예정임에 따라, 국내외 허가사항, 관련문헌(교과서, 임상진료지침, 임상연구문헌) 및 학회의견(전문가의견) 등을 고려하여 급여기준을 신설함



■ 관련문헌 등

1. Campbell-Walsh-Wein Urology, 13e. 2025, Chapter 150 Evaluation and Nonsurgical Management of Benign Prostatic Hyperplasia

2. Goldman-Cecil Medicine, 27e, 2023, Chapter: 114 Benign Prostatic Hyperplasia and Prostatitis

3. 전립선비대증 진료권고안, 대한비뇨기과학회, 2015

4. MANAGEMENT OF LOWER URINARY TRACT SYMPTOMS ATTRIBUTED TO BENIGN PROSTATIC HYPERPLASIA: AUA GUIDELINE (Published 2021; Amended 2023)

5. EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS)(2025)

6. 신경인성방광 지침서, 대한배뇨장애요실금학회, 2011

7. EAU Guidelines on Neuro-Urology(2024)

8. The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction (American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU)) Guideline Statements(2021)

9. Philip van Kerrebroeck et al. Combination Therapy with Solifenacin and Tamsulosin Oral Controlled Absorption System in a Single Tablet for Lower Urinary Tract Symptoms in Men: Efficacy and Safety Results from the Randomised Controlled NEPTUNE Trial. EUROPEAN UROLOGY. 2013;64:1003？1012.

10. Marcus J. Drake et al. Long-term Safety and Efficacy of Single-tablet Combinations of Solifenacin and Tamsulosin Oral Controlled Absorption System in Men with Storage and Voiding Lower Urinary Tract Symptoms: Results from the NEPTUNE Study and NEPTUNE II Open-label Extension. EUROPEAN UROLOGY. 2015;67:262？270